Amlostin Tablets

PATIENT INFORMATION LEAFLET

Amlostin 5mg and 10mg Tablets

(Amlodipine Maleate)

Please read this leaflet carefully before you start taking Amlostin Tablets.

Keep this leaflet safe, as you may need to read it again.

If you have further questions, please ask your doctor or pharmacist.

What is in your medicine?

The name of your medicine is Amlostin Tablets. There are two strengths as follows:

• Amlostin 5mg Tablets are white, round tablets. Each tablet contains 5 mg of the active ingredient amlodipine (as amlodipine maleate).
• Amlostin 10mg Tablets are white, round tablets with a break score on both sides. Each tablet contains 10 mg of the active ingredient amlodipine (as amlodipine maleate).

The tablets also contain the following inactive ingredients: lactose monohydrate, povidone K 30, povidone K 90, microcrystalline cellulose, crospovidone and sodium stearyl fumarate.

Your medicine is available in blister packs containing 28 tablets.

What is amlodipine?

Amlodipine belongs to a group of medicines known as calcium-channel blockers (calcium antagonists). It prevents too many calcium particles entering the heart muscle, which helps to lower blood pressure. Amlostin Tablets are used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including vasospastic angina. In patients with high blood pressure these tablets work by relaxing blood vessels, so that blood passes through them more easily.

Before you take these tablets

How to take your tablets

The label on the carton will tell you how many tablets you should take and when. Follow your doctor’s advice. The tablets should be swallowed whole with a glass of water. Take your tablets at the same time each day, independently from meals.

Adults: the usual starting dose is one 5 mg tablet daily. The dose may be increased after 2-4 weeks to a maximum daily dose of one 10 mg tablet. Your doctor may prescribe you other drug treatments for angina whilst you are taking these tablets.

Elderly: The dosing regimen is the same as for adults. If your dose is increased to one 10 mg tablet, your doctor will closely monitor your response.

Patients with kidney disease: The dosing regimen is the same as for adults.

Patients with liver disease: Your doctor will decide your dosing regimen. Your response to the treatment should be closely monitored.

Amlostin Tablets are NOT recommended for children under 18 years of age.

Possible side effects

Like all medicines Amlostin Tablets may cause some unwanted side effects in some people. However, not everyone gets side effects.

Please consult your doctor immediately if you experience any of the following:

Very common: occurs in more than 1 in 10 patients

• ankle swelling.

Common: occurs in more than 1 in 100 but less than 1 in 10 patients

• headache and flushing of the face (especially in the beginning of treatment)
• feeling tired, dizziness, feeling weak, palpitations (a quick or irregular heart beat)
• feeling sick, indigestion, stomach-ache.

Uncommon: occurs in more than 1 in 1000 but less than 1 in 100 patients

• increase or decrease in weight, feeling unwell with general aches and pains, dry mouth
• uncontrolled shaking (tremor), pins and needles, increased sweating
• unable to sleep, feeling irritable, depression
• low blood pressure, feeling faint, increased heart rate, chest pain (especially at the beginning of treatment)
• shortness of breath, inflammation inside the nose, problems with sight
• vomiting (being sick), diarrhoea, constipation, swelling or soreness of the gums
• skin problems such as discoloration, rash or eruption (e.g. nettle rash or hives), itching, hair loss
• muscle or joint pain, back pain, muscle cramps
• inability to obtain an erection, enlargement of the male breasts, increased need to urinate.

Isolated cases of heart attack, irregular heart beat and chest pain have been reported in patients suffering with heart disease although no clear association with amlodipine has been established.

Rare: occurs in more than 1 in 10,000 but less than 1 in 1000 patients

• changes in sense of taste
• confusion, mood changes, feeling worried
• abnormal liver function, inflammation of the liver, yellowing of the skin or whites of the eyes
• tinnitus (ringing or buzzing in the ears).

Very rare: occurs in less than 1 in 10,000 patients

• low numbers of white blood cells and/or platelets, excess sugar in the blood
• numbness in fingers or toes
• damage to small blood vessels causing purple spots or blotches on the skin
• cough, inflamed stomach lining, inflamed pancreas
• angio-oedema (swelling of the lips, eyes or tongue), local swelling causing wheals on the skin.

There have been isolated cases of serious allergic reactions including itchy skin, rash, red patches, scaling on skin and swelling of the face, eyes or lips. These reports are however very rare.

How should you store these tablets?

Do not store your tablets above 25ºC. Store in the original pack.

Do not take the tablets after the expiry date printed on the carton and blister.

Please return any tablets you have not used to a pharmacist.

Keep all medicines out of the reach and sight of children.

Remember: These tablets have been prescribed for you personally. Please do not give them to anyone else. It may harm them, even if they have the same symptoms as you.

Marketing Authorisation Numbers:

• Amlostin 5mg Tablets PL 06831/0106
• Amlostin 10mg Tablets PL 06831/0107

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